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YY 0782-2010

Chinese Standard: 'YY 0782-2010'
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YY 0782-2010English1049 Add to Cart Days<=8 Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs Valid YY 0782-2010
YY 0782-2010Chinese49 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY 0782-2010 (YY0782-2010)
Description (Translated English) Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C39
Classification of International Standard 11.040.60
Word Count Estimation 77,727
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Adopted Standard IEC 60601-2-51-2003, IDT
Drafting Organization Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the type of recording and analyzing single channel and multi-channel ECG machine safety requirements and basic performance requirements. Single-channel and multi-channel ECG machine has been carried out in 2. 101, 2. 111, 2. 117, 2. 123, 2. 126 defined, hereinafter referred to as devices. Such equipment may not be left unattended or unsupervised. The specific standard complements GB 10793-2000.

YY 0782-2010
Medical electrical equipment.Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs
ICS 11.040.60
C39
People's Republic of China pharmaceutical industry standards
YY 0782-2010/IEC 60601-2-51.2003
Medical electrical equipment - Part 2-51.
Recording and analysis of single and multi-channel ECG machine safety
And essential performance
Part 2-51. Particularrequirementsforsafety, includingessentialperformance,
(IEC 60601-2-51.2003, IDT)
Issued on. 2012-06-01 2010-12-27 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅳ
Introduction Ⅴ
The first chapter outlines
1 Scope and purpose 1
1.1 * Range 1
1.2 Objective 1
1.3 Specific Standard 1
2 Terms and definitions 2
4 4 General test requirements
6 Identification, marking and documents 5
The second environmental conditions
Third of the risk of electric shock protection
Title IV of the mechanical hazards Protection
The fifth chapter of unwanted or excessive radiation hazard protection
Title VI of flammable anesthetic mixture ignition risk protection
Title VII of the over-temperature and other security risk protection
Protection accuracy and dangerous work output data of the eighth chapter
7 50 Operating data accuracy
51 protection dangerous output 14
Chapter 9. abnormal operation and fault conditions; Environmental Testing
Tenth Canto structural requirements
56 26 components and subassemblies
Annex L (normative) --- standard reference publications mentioned in 32
Annex AA (informative) Theoretical and General Guidelines 33
Appendix BB (informative) electrode, the electrode position, definition and color code 39
YY 0782-2010/IEC 60601-2-51.2003
Annex CC (informative) leads the definition of leads (Definitions In addition to the 51.101) 41
Appendix DD (informative) polarity of patient leads (Definitions In addition to the 51.101) 43
Other electrode identification Appendix EE (informative) 44
Appendix FF (normative) Noise 46
Appendix GG (normative) definitions and rules ECG 48
Appendix HH (normative) Calibration and testing database 54
Appendix II (Information Appendix) CTS test pattern 57
References 67
Index 68
101 According to Frank electrode position (see Table 101) 27
102 patients polar leads (see 51.101.1) 27
103 Weighted network and input impedance of the test pattern (see 51.101.2.2 and 51.102.1) 27
Figure 104 CMR test (see 51.105.1 and 51.106.4) 28
105 Table 114 Test E triangular wave (see 51.107.1.1.1) 29
106 input pulse signal (dashed line) and ECG response (solid line) (see 51.107.1.1.2) 29
Linearity test circuit 107 (see 51.107.2) 30
Linearity test results in Fig. 108 (see 51.107.2) 30
109 test results rectangle coordinates (see. 51.108.4.1) 31
Figure BB.1a) leads with color fetal ECG (see 6.1, table BB.1) 40
Figure BB.1b) Fetal Fetal ECG electrode positions (6.1, Table BB.1) 40
Figure BB.2 fetal scalp ECG lead position and color (see 6.1, table BB.1) 40
Figure CC.1 Frank lead system network 42
Figure EE.1 Code 1 correspondence between the electrodes and the color 44
Figure FF.1 patients with ECG machine is connected to the analog circuit 46
Figure FF.2 typical ECG input circuit configuration and equivalent circuit 47
FIG GG.1 normal ECG 48
FIG. 49 is determined GG.2 whole period between
Figure GG.3 time waveform, and other potential section 50
Figure GG.4 acceptable small R wave of the QRS complex 52
Figure GG.5 small R wave unacceptable QRS complex 52
Figure GG.6 was identified as a detailed illustration of small R wave 53
Figure GG.7 not be recognized as a detailed illustration of small R wave 53
Figure II.1 CTS test system 58
Example Figure II.2 signal conditioning circuit 59
Figure II.3 calibration term ECG signals by naming 61
ECG signal with the terms defined analysis 64 Figure II.4
Figure II.5 noise 65
Table 101 electrode and neutral electrode location, logo and color code 6
Table 102 data through a 3.2s time constant of a first-order high-pass filter, the ST segment and T wave generated by the bias voltage
Amplitude reference value 8
YY 0782-2010/IEC 60601-2-51.2003
Table 103 using the calibration and analysis between the overall time period and Q, R and S-wave measurement of ECG data acceptable
The mean and standard deviation of 9
Table 104 using the actual body overall ECG interval measurements and time frames acceptable average error and standard deviation of 9
The change in the measurement result table 105 ECG caused by noise announcement (using Table HH.3 listed electrocardiogram data) 10
Table 11 lists the results of the test 106
Table 107 publicly explain the format of the diagnostic accuracy of 12
Table 108 discloses rhythm diagnostic accuracy 13 format
Electrode connection table 109 of a particular lead 14
Table 110 leads its identification (name and definition) 14
Table 111 Goldberger and Wilson lead network 16
Table 112 Frank (Frank) network leads 17
Table 113 Input impedance - Lead selector position, the case of connecting the lead electrode and the opening of the output waveform S1
Peak - valley amplitude 18
Table 114 Frequency response 22
Table BB.1 electrode, the electrode position, definition and color code (see further description of 6.1, table 101) 39
Table 43 DD.1 electrode polarity
Table EE.1 14 wire patient cable color code identifies 45 recommendations
Table HH.1 calibration and analysis of ECG data 54
The actual human electrocardiogram table HH.2 for testing ECG measurements and waveform recognition accuracy database 55
Test Data Sheet HH.3 stability with anti-noise 56
Table II.1 named signal (ECG signal calibration) 62
Table name II.2 signal (ECG signal analysis) 64
YY 0782-2010/IEC 60601-2-51.2003
Foreword
Medical electrical equipment standard series of standards, the series standard consists of two parts.
--- Part 1. General requirements for safety of medical electrical equipment;
--- Part 2. Medical electrical equipment requirements for the safety.
This special standard - Part 2-51 Medical electrical equipment. The specific standard is based on GB 9706.1-2007 "Medical Electrical Equipment
Part 1. General Requirements for Safety "(hereinafter. General Standard) of the specific standards, it is GB 9706.1 of changes and additions,
And supporting the use of GB 9706.1.
The use of specific standard translation method identical with IEC 60601-2-51.2003 "Medical electrical equipment - Part 2-51. recording and analysis
Single and multi-channel ECG machine safety and essential performance. "
The specific standard IEC 60601-2-51.2003 made the following editorial changes.
--- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;
--- Remove IEC 60601-2-51.2003 cover and foreword, according to GB/T 1.1 standards require rewriting;
The specific standard of medical equipment by the National Standardization Technical Committee of Standardization Technical Committee of Medical Appliances (SAC/TC10 /
SC5) centralized.
The specific standard drafting unit. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen Edan Precision Instrument Co., Ltd., Shanghai Medical
Spa instrument detection.
The main drafters of this specific standard. Ye Wenyu Xie Xicheng, Shiwen Li, Ye Jilun.
YY 0782-2010/IEC 60601-2-51.2003
introduction
This standard relates to special additional safety records and analysis of single and multi-channel ECG device. It changes and additions
The GB 9706.1-2007, hereinafter referred to as the universal standard version. The specific requirements of the standard in preference to "Medical Electrical Equipment Part 1
Score. General Requirements for Safety "common standards.
For the "general guidelines and basic principles," the special requirements of this standard in Annex AA.
Standard text in front of the reg number raises a "*" indicates that provision in Annex AA further explanation and clarification.
We believe that these requirements will not only help to understand the proper use of this standard, and in time to accelerate due to changes in clinical practice or
Technological development and to accelerate the standard revision process. However, this is not a standard part of the Appendix of this requirement.
YY 0782-2010/IEC 60601-2-51.2003
Medical electrical equipment - Part 2-51.
Recording and analysis of single and multi-channel ECG machine safety
And essential performance
The first chapter outlines
In addition to the following, the common standards Benpian apply.
1 Scope and purpose
In addition to the following, the common standards in this chapter apply.
1.1 * Range
Addition.
This standard specifies the special safety requirements for recording and analyzing single channel and multi-channel ECG machine and the basic performance requirements. Single-channel and multi-channel heart
FIG electric machine has been defined in the 2.101,2.111,2.117,2.123,2.126, hereinafter referred to as devices. Such equipment may have been
Custody or unattended.
This special supplement standard GB 10793-2000.
1.2 Purpose
Alternative.
In addition to GB 10793-2000 in terms of security made some additional requirements beyond the specific purpose of the standard is to establish a close
For recording and analyzing single channel and multi-channel ECG machine safety and essential performance of special requirements.
The only requirements for particular application.
--- Type recording ECG;
--- ECG machine, ECG machine that is part of one of the other medical electrical equipment, such as exercise test system, if the ECG
FIG machine is used to record the ECG and for diagnostic purposes;
--- ECG is used as the database management system of the output unit of the ECG machine, or place in the absence of a recording device as an output
ECG unit;
--- Analytical ECG machines, systems and computing equipment, which by electrocardiogram electronic data processing and pattern recognition approach
Measurement (such as intervals and amplitudes) and diagnostic instructions;
--- Having realized analytical analysis of patient ECG monitor ECG or other special part of ECG machine.
This standard does not apply to Holter ECG, invasive ECG, patient monitoring systems, and other high-resolution other than the above
ECG (electrocardiogram machine such as HIS bundle with late potential detection of ECG).
1.3 Specific Standard
Addition.
The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and GB 10793-2000
"Medical electrical equipment - Part 2-25. ECG requirements for the safety."
YY 0782-2010/IEC 60601-2-51.2003
Related standard: YY 0781-2010    YY 0783-2010
Related PDF sample: YY 0896-2013    YY/T 1519-2017